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New kidney drug B007 takes on cyclosporine in major trial

NCT ID NCT06470191

Disease control Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, B007, against the standard treatment cyclosporine for people with primary membranous nephropathy, a kidney disease that causes protein leakage. About 216 adults with confirmed disease and adequate kidney function will be randomly assigned to receive either B007 or cyclosporine. The main goal is to see if B007 leads to more remissions (improvement) and has fewer side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy; 2. Subjects with glomerular filtration rate（eGFR） ≥ 45 mL/min/1.73 m2. 3. If taking Angiotensin converting enzyme inhibitors/angiotensin II receptor antagonists/sodium-glucose cotransporter 2 inhibitors/endothelin inhibitors, a stable dose within 4 weeks before randomization; 4. Subjects with 24-hour elevated urinary protein in accordance with the prescribed conditions; 5. Subjects whose laboratory test results meet the prescribed standards during the screening period; 6. Subjects who have fully understood this study and voluntarily signed the informed consent form； 7. Subjects who are able to follow the study protocol as judged by the investigator. Exclusion Criteria: 1. Subjects with secondary membranous nephropathy or primary membranous nephropathy whose pathological reports suggest concomitant crescent bodies; 2. Subjects identified by the investigator as previously resistant to CD20 monoclonal antibody or cyclosporine; 3. Subjects who have received medication prescribed for membranous nephropathy; 4. Subjects with concomitant prescribed diseases; 5. Subjects with a known history of severe allergic reactions to humanized monoclonal antibodies, or known allergies to any component of cyclosporine or B007; 6. Subjects who received live vaccination, major surgery, or participated in other clinical trials within 28 days before receiving the study drug; 7. Subjects with positive hepatitis B surface antigen; those with positive hepatitis C virus antibody; those with a history of immunodeficiency or suffer from other acquired or congenital immunodeficiency diseases; 8. Subjects who have a clear history of tuberculosis or have received anti-tuberculosis treatment; 9. Subjects with CD4+ T lymphocyte count \< 400 cells/μL; 10. Pregnant or lactating women; women of childbearing potential who have not been sterilized do not agree to use appropriate contraceptive measures during treatment and for at least 12 months after the last dose of the study drug; 11. For male subjects who have not been sterilized: those who do not consent to the use of barrier contraception during the study period and for at least 12 months after the last administration of the study drug, and who do not consent to the use of other contraceptive methods by their spouses; 12. Other conditions unsuitable for participation in this study determined by the Investigator.

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Conditions

The condition(s) this trial relates to.

idiopathic membranous glomerulonephritis membranous glomerulonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary membranous nephropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Nantong University

    RECRUITING

    Nantong, China

  • Beijing Tsinghua Changgung Hospital

    RECRUITING

    Beijing, China

  • Northern Jiangsu People's Hospital

    RECRUITING

    Yangzhou, China

  • Northern Theater Command General Hospital

    RECRUITING

    Shenyang, China

  • Peking University Shenzhen Hospital

    RECRUITING

    Shenzhen, China

  • Peking university first hospital

    RECRUITING

    Beijing, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, China

  • Shandong Provincial Hospital

    RECRUITING

    Jinan, China

  • Shengjing Hospital affiliated to China Medical University

    RECRUITING

    Shenyang, China

  • Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, China

  • The First Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, China

  • The First People's Hospital of Zigong

    RECRUITING

    Zigong, China

  • The Second Affiliated Hospital of Xingtai Medical college

    RECRUITING

    Xingtai, China

  • The Second Norman Bethune Hospital of Jilin University

    RECRUITING

    Changchun, China

  • Wuxi People's Hospital

    RECRUITING

    Wuxi, China

  • Xi'an Daxing Hospital

    RECRUITING

    Xi'an, China

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, China

  • Zhujiang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.